Refractory B-Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas
This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer [NK] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as AFM13, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving AFM13 loaded with NK cells followed by AFM13 alone may kill more cancer cells and decrease cancer growth in patients with CD30 positive AFM13-NK Hodgkin and Non-Hodgkin lymphomas.
PRIMARY OBJECTIVE: I. To establish the safety and recommended phase II dose of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13-NK), followed by intravenous anti-CD30/CD16A monoclonal antibody AFM13 (AFM13) in patients with refractory/relapsed CD30-positive lymphoid malignancies based on incidence of dose limiting toxicities (DLTs) per dose level. (Phase I) II. To assess the activity of umbilical cord blood (CB)-derived natural killer (NK) cells preloaded with the bispecific antibody AFM13 (AFM13- NK), followed by intravenous AFM13 in patients with refractory/relapsed CD30-positive lymphoid malignancies. based on overall response rate (ORR), complete response (CR) rate and partial response (PR) rate. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the duration of response. II. To evaluate the event-free survival (EFS) rate. III. To evaluate the overall survival (OS) time. IV. To quantify the persistence of infused donor CB AFM13-NK cells in the recipient. V. To conduct comprehensive immune reconstitution studies. OUTLINE: This is a dose-escalation study of AFM13-NK. Patients receive standard of care fludarabine intravenously (IV) over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. After completion of study treatment, patients are followed up at 28 days, 8 weeks, 100 and 180 days and then every 3-6 months for 2 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04635683 -
Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05801913 -
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT03925428 -
Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
|
Phase 1 | |
| Completed |
NCT01921387 -
Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04892277 -
CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
|
Phase 1 | |
| Withdrawn |
NCT03579927 -
CAR.CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood NK Cells, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Participants With B-cell Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01701986 -
Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04578600 -
CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT04447716 -
An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment
|
Phase 1 | |
| Recruiting |
NCT05272384 -
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
|
Phase 1 | |
| Terminated |
NCT03103971 -
huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
|
Phase 1 | |
| Completed |
NCT01729806 -
Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05053971 -
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Terminated |
NCT01434472 -
High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04637763 -
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
|
Phase 1 | |
| Active, not recruiting |
NCT02628405 -
R-ICE and Lenalidomide in Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04684472 -
Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
|
Phase 1 | |
| Enrolling by invitation |
NCT05332054 -
Long-Term Follow-up Study
|
||
| Recruiting |
NCT06313957 -
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05627245 -
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
|
Phase 1 |